Research Svcs ConsuItant II
In collaboration with the VU Human Research Protections Program, the Research Services Consultant II (RSC II) assists with the optimal application of the Federal, State, and local laws, guidance documents, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VU research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The RSC II researches topics of departmental, institutional or strategic importance.
Serves as the central resource for the research community to provide expertise and guidance on complex issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
Participates and leads institutional activities regarding culture and regulatory issues related to research.
Monitors and analyzes new legislation, Federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community.
Provides expertise to departments, institutional committees, Investigators, research staff, and students on procedures and operating practices for the research community on human research protections and good clinical practices.
Interfaces and partners with regulatory bodies who influence policies and regulations that affect research.
Establishes and maintains communications with institutional committees, Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research.
May represent the research community on various advisory and operating committees, as appropriate.
Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budgets, process improvement plans, and efficient time lines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols as appropriate.
Guides Investigators and key study personnel in the development of protocols and study budgets to capture all study costs and compliance with regulations; and assures adherence to FDA and other regulatory guidelines.
Develops and implements training programs on the strategic application of IRB policies and procedures, Federal mandates and guidelines, NIH, GCP/ICH guidance, and other applicable topics (e.g. budget development, research billing, grants, contracts, COI) for the VU Human Research Protections Program.
Critically analyzes current research practices and policies through observation, data collection, peer reviews, interviews, and industry analysis to assess quality of existing workflow processes and identify improvements needed to maximize quality and efficiency of human research protections programs.
Analyzes cost estimates and budget requests developed for planning and projecting human research protections program activities.
Assists with the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.
Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise.
Develops and implements quality assurance and regulatory strategies for the VU research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements, and recommends to the appropriate departmental officials activities and resources required to support this strategy.
Defines, establishes, and assures compliance with all internal standard operating procedures consistent with Federal standards for designing, conducting, recording, and reporting research within the Research Enterprise.
Provides ongoing assistance, consultation, and education to research personnel regarding quality assurance audits; clarifies data discrepancies and deviations from standing operating procedures. Analyzes results and assists in the development of a preventive action plan for potential future discrepancies.
Designs and develops audit measures based on general standard operating procedures and prepares checklists for inspections and compliance monitoring.
Conducts internal and external audits of research at periodic intervals to identify and analyze data errors, data discrepancies, process errors, and deviations from study protocols to assure compliance with applicable regulatory requirements and standard operating procedures.
Promotes compliance through detection, resolution, and reporting of research activities that do not conform to Federal, State, and local laws, Institutional policies and procedures.
Performs statistical analysis to identify data discrepancies and to determine error rates/trends; develops, prepares, and presents audit reports, as required.
Responsible for the comprehension, management, and facilitation of IRB regulatory assurance(s), contracts, agreements, and IRB policies and procedures.
Monitors and reports developments regarding Federal, State, and local laws, and research enterprise policies and procedures that impact institutional initiatives.
Manages and develops effective working relationships with customers by seeking, interpreting, and responding to feedback. Contributes to developing standards of conduct and feedback methods.
Monitors the development, approval, periodic review, revision, interpretation, version control, and historical archival to prevent inconsistencies and discrepancies of VU research community, programs, and departmental procedures, assurances, contracts, and agreements.
Develops, implements, and documents meaningful educational activities for IRB Staff, IRB Committee Members, VU Administration, and VU Principal Investigators in conjunction with Team Leaders. Responsible for creating and implementing IRB professional development plan and budget.
Assists and provides guidance for the research enterprise with budget development, analysis, financial risk assessment, billing compliance, and grant writing support in adherence to regulatory requirements.
Assists investigators with developing effective tools to successfully conduct a research protocol analysis related to study costs and risk assessment.
Assists with the performance of Medicare Deemed (all applicable criteria met) trial assessment.
Actively demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.
Communicates and models values and mission of VUMC. Exhibits personal integrity and respect for others.
Treats all team members as unique individuals with valuable resources and skills that enhance the team.
Collaborates with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
Assures self-goals are aligned with departmental goals for success.
Takes responsibility for mistakes or bad decisions and learns from mistakes.
Accepts responsibility for improvement of one's performance through recognition of strengths and weaknesses, participation in professional development activities, and positive input in team growth.
Effectively participates and leads project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvement.
Bachelor's Degree and 6 years relevant experience
Licensure, Certification, and/or Registration (LCR):
Physical Requirements/Strengths needed & Physical Demands:
Occasional: Sitting: Remaining in seated position
Occasional: Standing: Remaining on one's feet without moving.
Occasional: Walking: Moving about on foot.
Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
Occasional: Push/Pull: Exerting force to move objects away from or toward.
Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
Occasional: Crawling: Moving about on hands and knees or hands and feet.
Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
Research Svcs ConsuItant II